ABPM. Operating Manual. Part 2: Hardware, description of device for custo screen 300/400/pediatric

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Transcription:

Operating Manual ABPM 1 Safety Hardware 3 Software 4 Hygiene Part : Operating characteristics: For automatic ABPM measurements lasting up to 7 hours MHW 0005 DK 1664 Version 001 1/01/018

018 custo med GmbH This Operating Manual may not be copied in its entirety or in part, duplicated in any form or by any means or translated into another language without the prior written consent of custo med GmbH. The manufacturer reserves the right to change the information in this Operating Manual without prior notice. The current version can be downloaded from our website: www.customed.de. CAUTION: This Operating Manual is part of a modular system, consisting of four parts. All four parts must be downloaded from the Internet or from a CD to ensure the Operating Manual is complete. MHW 0005 DK 1664 Version 001 1/01/018 custo med GmbH [] ABPM Hardware, custo screen 300/400/pediatric page

Operating Manual ABPM 1 Safety Hardware 3 Software 4 Hygiene Part : Table of contents.1 Symbols on the devices........................................................................4. Intended use..1 custo screen 300/400...............................................................5.. custo screen pediatric..............................................................5.3 Part names, components for the recording.............................................6.4 Device operation.4.1 custo screen 300/400/pediatric recorder.....................................8.4. Elements in the display.............................................................9.4.3 Error codes and their causes....................................................10.5 Attaching the recorder to the patient..................................................1.6 Patient instructions...........................................................................13.7 Technical data and system requirements..............................................14.8 Manufacturer s declaration regarding EMC...........................................18.9 EC Declaration of Conformity.............................................................1.10 List of product components and accessories.........................................3 MHW 0005 DK 1664 Version 001 1/01/018 custo med GmbH [] ABPM Hardware, custo screen 300/400/pediatric page 3

ABPM.1 Symbols on the devices Manufacturer: custo med GmbH, Maria-Merian-Str. 6, 8551 Ottobrunn, Germany CE mark Safety class classification of medical electrical equipment according to DIN EN 60601-1 (Type BF) custo screen 300/400: The device is suitable for children aged ten and older (not for newborns and small children). custo screen pediatric: The device is suitable for children aged between three and twelve years (not for newborns and small children). Non-ionising electromagnetic radiation, device contains an RF transmitter (the radio unit of custo screen 300 is not active) Symbol on the custo screen 400 recorder for the insertion direction of the mini SD card (custo flash card mini) The sticker specifies the date when the next metrological check is due. Contact your authorised custo med dealer. 4 3 1 14 5 15 6 7 Ottobrunn MTK gültig bis: 16 8 17 18 9 10 19 11 1 Observe the Operating Manual Separate collection of electrical and electronic equipment, do not dispose with domestic waste MHW 0005 DK 1664 Version 001 1/01/018 custo med GmbH [] ABPM Hardware, custo screen 300/400/pediatric page 4

. Intended use..1 custo screen 300/400 custo screen 300/400 is an ABPM recorder with an internal power supply which is used to record and evaluate the blood pressure behaviour of a patient. The recording time can last for up to 7 hours. custo screen 300/400 is perfectly safe for use by patients with a pacemaker. The system is intended for use by trained specialist staff or physicians in clinics and medical practices. Patients are only allowed to use the recording device after receiving instruction by trained specialist staff. Patients who are not capable of understanding and following the instructions given are not allowed to use the device. This applies in particular to senile patients or patients suffering from dementia. The device is not suitable for unsupervised use with unconscious patients... custo screen pediatric custo screen pediatric is an ABPM recorder with an internal power supply which is used to record and evaluate the blood pressure behaviour of children. The recording time can last for up to 7 hours. custo screen pediatric is intended for use by general practitioners and medical specialists and also designed for hospitals and clinics. custo screen pediatric is intended for use on children 1). The device is not suitable for newborns and small children (patients must be aged at least: 3 years). 1) Definition according to DIN EN 80601--30:016-0: Newborns < 1 month Toddlers < 3 years Children > 3 years Before an examination can be carried out, a physician's approval must be obtained and one of the parents must have received detailed instruction by trained specialist staff. The device must not be used for recordings on child patients who are not able to endure the examination. The device is not suitable for unsupervised use with unconscious patients. It is only permitted to carry out an examination if it is ensured that the child patient is supervised during the entire period of recording as there is a risk of strangulation. MHW 0005 DK 1664 Version 001 1/01/018 custo med GmbH [] ABPM Hardware, custo screen 300/400/pediatric page 5

.3 Part names, components for the recording custo screen 300/400/pediatric ABPM recorder (custo screen pedriatric featuring child-friendly motifs on the battery compartment cover, see the illustrations on the right) Cuff with retainer standard, additional cuff sizes are available, see Chapter.7 Technical data and system requirements and.10 List of product components and accessories Carrying case for the ABPM recorder Carrying belt, depending on the type of recorder in different lengths: custo screen 300/400: 17 cm, optionally 155 cm long custo screen pediatric: Child belt 96 cm Batteries (set of 3) Mignon 1.5 Volt, type AA custo com IR infrared interface USB extension cable.0, type B mini,.0 m MHW 0005 DK 1664 Version 001 1/01/018 custo med GmbH [] ABPM Hardware, custo screen 300/400/pediatric page 6

Tip: custo screen protect hygiene set Six washable fleece pads for more hygiene and comfort when wearing the blood pressure cuff. Worn underneath the cuff with the soft side on the skin. MHW 0005 DK 1664 Version 001 1/01/018 custo med GmbH [] ABPM Hardware, custo screen 300/400/pediatric page 7

.4 Device operation.4.1 custo screen 300/400/pediatric recorder Inserting the batteries or rechargeable batteries Open the battery compartment as depicted and insert three commercially available batteries. The direction of insertion is shown on the illustrations in the battery compartment. Functional elements of the device On/off switch: for switching the recorder on and off I = on 0 = off Infrared interface for transmitting data between custo screen 300/400/pediatric and PC Cuff port (BNC) Card slot for mini SD card (only with custo screen 400) Function key for starting and stopping measurements Display for displaying results and messages MHW 0005 DK 1664 Version 001 1/01/018 custo med GmbH [] ABPM Hardware, custo screen 300/400/pediatric page 8

.4. Elements in the display Sys: Systolic blood pressure Dia: Diastolic blood pressure P: Pulse Battery: Lights up if the batteries are weak If the blood pressure measurement has been carried out successfully... systole, diastole and pulse will be displayed three times in succession During the data transmission between the recorder and the PC... "PC" is shown on the display (the light-emitting diode of the custo com IR infrared interface flashes) In the event of erroneous measurements... an error code is shown on the display, e.g. "E06" MHW 0005 DK 1664 Version 001 1/01/018 custo med GmbH [] ABPM Hardware, custo screen 300/400/pediatric page 9

.4.3 Error codes and their causes Error when reading or writing the time Internal electric double-layer capacitor (energy store for the time) discharged Insert batteries, switch device on Thresholds are fallen below or exceeded Sys: < 70 mmhg > 70 mmhg, Dia: < 40 mmhg > 155 mmhg Sys - Dia: < 15 mmhg HR: < 35/min > 0/min Measurement is repeated automatically Pressure discharge rate outside the given limits Valve is leaking or defective Customer service Disturbed measurement Too many movement artefacts Cuff slipped or not tight enough Attach the cuff carefully and keep the arm steady during the measurement Battery voltage too low Insert new batteries or freshly charged rechargeable batteries into the recorder Pressure sensors transmit different values Cuff tube kinked BNC port at the recorder or cuff tube dirty One of the pressure sensors is faulty Remove cuff from device, connect it again and repeat procedure If the error persists, call customer service Pressure increase is too slow Cuff is not connected or cuff/valve is leaking/defective Connect cuff if necessary Check cuff (sealing ring in connection present/ok?) If the error persists, call customer service MHW 0005 DK 1664 Version 001 1/01/018 custo med GmbH [] ABPM Hardware, custo screen 300/400/pediatric page 10

Pressure increase is too fast Cuff tube is kinked, valve system is clogged Align the cuff tube If the error persists, call customer service Discharge period is too long Cuff tube is kinked, valve is defective Customer service if multiple occurrences during a recording Error when determining diastole Cuff attached incorrectly, marking is not situated on the artery, movement artefacts Attach the cuff carefully and keep the arm steady during the measurement Error when determining systole Cuff attached incorrectly, marking is not situated on the artery, movement artefacts Attach the cuff carefully and keep the arm steady during the measurement In the event of an erroneous measurement, the measurement is repeated after two minutes. If errors occur that are not listed here, switch the device off and back on again. Repeat the desired step. If the error persists, contact your authorised custo med dealer. MHW 0005 DK 1664 Version 001 1/01/018 custo med GmbH [] ABPM Hardware, custo screen 300/400/pediatric page 11

.5 Attaching the recorder to the patient Attaching the blood pressure cuff Make sure to select the correct cuff size for the patient. Each cuff contains information for which arm circumference it is suited, e.g. standard 4 3 cm. Attach the cuff to the left upper arm, two to three centimetres above the crook of the arm. Apply the cuff in such a way that the marking is situated on the brachial artery. The cuff must not be attached too firmly. It should still be possible to fit approximately two fingers between the arm and the cuff. Lay the cuff tube from the left shoulder over the right shoulder to the right hip. There the recorder will be placed later. Fix the cuff and the tube to the patient s body. This serves to avoid erroneous measurements due to incorrect positioning of the cuff or tube. Use professional fixing aids with a low level of adhesive residues. Attaching the belt with the carrying case Attach the carrying case to the carrying belt. Put the carrying belt on the patient. The case should be positioned on the patient s right hip. Put the switchedon recorder into the carrying case and close it with the hook and loop fastener. Connect the cuff tube to the recorder as illustrated. Sample measurement Press the function key in order to carry out a sample measurement. Take care that the patient keeps still during the measurement. In the event of an erroneous measurement, improve the fitting of the cuff and the tube. If the sample measurement is successful, patient and recorder are ready for recording. MHW 0005 DK 1664 Version 001 1/01/018 custo med GmbH [] ABPM Hardware, custo screen 300/400/pediatric page 1

.6 Patient instructions Handling of the recorder The day on which the recording is made should be planned as normally as possible (no day off, no exceptional events). The switched-on recorder and the cuff must also be worn during the night. No x-rays must be taken on the day of recording. Sources of interference, such as stimulation current devices, are to be avoided. Each measurement is announced with a beep (unless this function is deactivated in custo diagnostic). Using default settings, the measurements are performed every 15 minutes during the day and every 30 minutes during the night. The recorder must be protected against extreme cold, heat, moisture, dirt and mechanical impact. No showers, no visits to the swimming pool and sauna. The patient is not allowed to remove the batteries or rechargeable batteries or modify the device in any way. Do not leave small children unattended with the device. Risk of strangulation with provided cables and belts, risk of suffocation from small parts that could be swallowed. Avoiding erroneous measurements The patient must keep still during the measurement. The cuff tube must not be kinked. A repeat measurement is automatically performed two minutes after an erroneous measurement. If several measurements are erroneous (especially E6, E1-4 and E5-8), it should be checked if the cuff is still positioned correctly. The marker should be located on the brachial artery and the cuff should be positioned on the arm so that approximately two fingers fit between the cuff and the arm. For further causes of erroneous measurements, see Chapter.4.3 Error codes and their causes Discomfort during the recording If the patient experiences discomfort during a recording, e.g. caused by a too high cuff pressure, the patient must contact his/her physician. The patient can stop the measurements at any time by pressing the function key or by opening the cuff s hook and loop fastener. Pregnant women should consider their individual physical endurance and contact their physician, if necessary. MHW 0005 DK 1664 Version 001 1/01/018 custo med GmbH [] ABPM Hardware, custo screen 300/400/pediatric page 13

.7 Technical data and system requirements custo screen 300/400/pediatric Measurement method Measuring range Oscillometric measurement procedure, Automatic zero balancing custo screen pediatric Heart rate 35 0 beats / min Systolic blood pressure 50 160 mmhg Diastolic blood pressure 30 110 mmhg Measurement accuracy [mmhg] custo screen 300/400 Heart rate 35 0 beats / min Systolic blood pressure 70 70 mmhg Diastolic blood pressure 40 155 mmhg custo screen pediatric Systole Diastole Deviation from the average value -1.4-0.7 Standard deviation 3 3. custo screen 300/400 Systole Diastole Deviation from the average value -0.5-0.1 Standard deviation 4.5 3.3 Meets the requirements of the ESH International Protocol 010 Max. number of measurements 500 Max. recording time 7 hours for ABPM recordings 4 hours for Holter ABPM recordings (custo screen 400) Duration of one measurement approx. 30 seconds Measuring intervals Can be set to 5 to 90 minutes in the software Standard: every 15 minutes during the day, every 30 minutes at night Cuff pressure custo screen pediatric max. 00 mmhg custo screen 300/400 max. 300 mmhg pediatric 300/400 Cuff sizes Cuff with retainer standard 4 3 cm and compatibility with the Cuff with retainer x-large 3 40 cm recorder types Cuff with retainer xx-large 38 50 cm Bandage cuff pediatric 14 0 cm Bandage cuff small, child 0 4 cm Bandage cuff standard 4 3 cm Bandage cuff xx-large 38 50 cm Data transmission Infrared interface with USB port (IrDA standard) mini SD card for Holter ABPM (custo screen 400) Power supply 3 Mignon 1.5 V, type AA 3 rechargeable batteries, Ni-MH, 1. V, min. 1500 mah MHW 0005 DK 1664 Version 001 1/01/018 custo med GmbH [] ABPM Hardware, custo screen 300/400/pediatric page 14

Operating conditions Temperature +10 C... +45 C Air humidity 10... 95% rh Air pressure 700... 1060 hpa Transport and storage Temperature -0 C... +45 C conditions Air humidity 10... 95% rh Air pressure 700... 1060 hpa Dimensions Size approx. 100 * 66 * 6 mm (L * W * H) Weight approx. 159 g (without batteries) Classification Device with internal power supply Type BF Class IIa Applied standards DIN EN 60601-1, DIN EN 60601-1-, IEC 80601--30, DIN EN, 60601--47, Directive 93/4/EEC MHW 0005 DK 1664 Version 001 1/01/018 custo med GmbH [] ABPM Hardware, custo screen 300/400/pediatric page 15

General system requirements Operating system Windows 7 SP1 with current updates (3 bit and 64 bit operating system) Windows 8 (3 bit and 64 bit operating system) Windows 8.1 (3 bit and 64 bit operating system) Windows 10 (3 bit and 64 bit operating system) Windows Server 003 (3 bit and 64 bit operating system) Windows Server 008 (3 bit and 64 bit operating system) Windows Server 008 R Windows Server 01 Windows Server 01 R older versions are not supported PC The PC hardware should meet the minimum requirements of the operating system used. Provide additional RAM (1 GB) for custo diagnostic. Please ensure that there is sufficient free space on the hard disk for the custo diagnostic evaluations. The PC must meet the requirements of the safety standard DIN EN 60950 for information technology equipment. File sizes of the evaluations Holter approx. 15 MB (max. 60 MB) ABPM: approx. 18 KB (max. 51 KB) Holter ABPM: approx. 0 MB (max. 5 MB) Resting ECG: approx. 00 KB (for an ECG of approx. 10 sec.) Stress ECG: approx. 6 MB (for an ECG of approx. 0 min.) CPET: refer to stress ECG Spirometry: approx. 50 KB (max. 56 KB) Rehab: approx. 6 MB (for approx. 45 min. of exercise) MCT: approx. 10 15 MB for 4-hour ECG Hardware & ports DVD or CD-ROM drive, USB port MHW 0005 DK 1664 Version 001 1/01/018 custo med GmbH [] ABPM Hardware, custo screen 300/400/pediatric page 16

Recommended system requirements Computer Intel Core i3-cpu with HD graphics 4400 4 GB RAM 56 GB SSD or SSHD (for single-position systems TB HDD) 1 GBit network connection (not for single-position systems) Fanless Dual-DVI (or DP) graphics card (for CPET) Windows 8.1 x64 (PRO version for joining a domain) Ports One USB.0 port per USB device (preferably not USB 3.0) One COM port each for ergometer and treadmills (serial) At least Version 4.0 if Bluetooth is installed otherwise can be deactivated in the BIOS Monitor 0 TFT with DVI or DP port Full HD resolution Dual-TFT for spiroergometry Printer 600 dpi Monochrome (colour recommended for CPET) USB.0 port or network connection PCL-enabled (increases printing speed with the suitable driver) MHW 0005 DK 1664 Version 001 1/01/018 custo med GmbH [] ABPM Hardware, custo screen 300/400/pediatric page 17

.8 Manufacturer's declaration regarding EMC (electromagnetic compatibility) according to DIN EN 60601-1-:007 Manufacturer's declaration electromagnetic emissions The custo screen 300/400/pediatric ABPM recorder is designed for use in the electromagnetic environment stated below. The customer or user of the custo screen 300/400/pediatric should make sure that it is used in such an environment. Emission measurements RF emissions according to CISPR11 custo screen 300 custo screen pediatric RF emissions according to CISPR11 custo screen 400 (no electromagnetic energy is emitted during ABPM recordings, only during Holter ABPM recordings with a radio connection to the ECG transmitter) RF emissions according to CISPR11 Harmonics according to IEC61000-3- Voltage fluctuations/flickers according to IEC61000-3-3 Compliance Group 1 custo screen 300 custo screen pediatric Group custo screen 400 during Holter ABPM recordings Class B Not applicable Not applicable Electromagnetic environment - guidelines custo screen 300 / custo screen pediatric uses RF energy only for its internal function. Its level of RF emission is therefore very low and is unlikely to be sufficient to interfere with other electronic devices. custo screen 400 must emit electromagnetic energy in order to perform its intended function. Other electronic devices in the vicinity may be affected. custo screen 300/400 is designed for use in all establishments, including domestic establishments and those directly connected to the public low voltage power supply network that supplies buildings used for domestic purposes. Manufacturer s declaration electromagnetic immunity The custo screen 300/400/pediatric ABPM recorder is designed for use in the electromagnetic environment stated below. The customer or user of the custo screen 300/400/pediatric should make sure that it is used in such an environment. Immunity tests Electrostatic discharge (ESD) according to IEC 61000-4- IEC 60601 test level Compliance level ± 6 kv contact discharge ± 8 kv air discharge Electromagnetic environment - guidelines ± 6 kv contact discharge ± 8 kv air discharge Floors should be made of wood or concrete or be equipped with ceramic tiles. If the floor is provided with synthetic material, the relative air humidity must be at least 30 %. Fast transient electric interference factors/bursts according to IEC 61000-4-4 Surges according to IEC 61000-4-5 ± kv for net wires ± 1 kv for input and output wires ± 1 kv push-pull voltage ± kv push-push voltage Not applicable The quality of the supply voltage should correspond to that of a typical business or clinical environment. Not applicable The quality of the supply voltage should correspond to that of a typical business or clinical environment. Voltage drops, short-time interruptions and fluctuations in the supply voltage according to IEC 61000-4-11 < 5 % U T for 0.5 periods (> 95 % drop) 40 % U T for 5 periods (60% drop) 70 % U T for 5 periods (30% drop) < 5 % U T for 5 s (> 95 % drop) 3 A/m Not applicable The quality of the supply voltage should correspond to that of a typical business or clinical environment. If the user of the custo screen 300/400 requires continued operation, even if interruptions in the energy supply occur, it is recommended to supply the custo screen 300/400 from an uninterruptible power supply. Magnetic field with supply frequency (50/60 Hz) according to IEC 61000-4-8 3 A/m Magnetic fields with mains frequency should correspond to the typical values of a business and clinical environment. COMMENT: U T is the alternating supply voltage prior to application of test levels MHW 0005 DK 1664 Version 001 1/01/018 custo med GmbH [] ABPM Hardware, custo screen 300/400/pediatric page 18

Manufacturer s declaration electromagnetic immunity The custo screen 300/400/pediatric ABPM recorder is designed for use in the electromagnetic environment stated below. The customer or user of the custo screen 300/400/pediatric should make sure that it is used in such an environment. Immunity tests IEC 60601 test level Compliance level Electromagnetic environment - guidelines Portable and mobile radio sets should not be used at a closer distance to the device including the leads than the recommended protective distance which is determined according to the equation of transmitting frequency. Recommended protective distance: Conducted RF disturbances according to IEC 61000-4-6 3 V effective value 150 KHz to 80 MHz [U 1 ] V Not applicable d = (3.5/U1) P d = (3.5/E 1 ) P 80 MHz to 800 MHz Radiated RF disturbances according to IEC 61000-4-3 3 V/m 80 MHz to.5 GHz 3 V/m d = (7/E 1 ) P 800 MHz to.5 GHz with P as the nominal power of the transmitter in watt (W) according to the indications of the transmitter manufacturer and d as the recommended protective distance in meters (m). According to an examination on site a) the field strength of stationary radio transmitters should be lower than the compliance level with regard to all frequencies. In the vicinity of devices carrying the following symbol, interference is possible: COMMENT 1: With 80 MHz and 800 MHz the higher frequency range is valid. COMMENT : These guidelines may not apply in every case. The propagation of electromagnetic variables is influenced by absorptions and reflections of buildings, objects and people. a) The field strength of stationary transmitters, such as e.g. base stations of mobile phones and land mobile radios, amateur radio stations, AM and FM broadcasting as well as television networks cannot be exactly predetermined theoretically. In order to determine the electromagnetic environment regarding the stationary transmitters, a study of the location should be considered. If the measured field strength exceeds the abovementioned compliance levels at the location where the device is used, the device should be watched in order to prove the intended functions. If unusual performance features are observed, it may be necessary to take additional measures, for example reorienting or relocating the device. MHW 0005 DK 1664 Version 001 1/01/018 custo med GmbH [] ABPM Hardware, custo screen 300/400/pediatric page 19

Recommended protective distances between portable and mobile RF telecommunication devices and custo screen 300/400/pediatric custo screen 300/400/pediatric is designed for operation in an electromagnetic environment in which the RF transients are controlled. The user can help avoid electromagnetic interference by maintaining the minimum distance between portable and mobile RF telecommunication devices (transmitters) and the device depending on the power output of the communication device, as indicated below. Protective distance depending on the transmitting frequency in m Nominal power of the transmitter 150 khz to 80 MHz 80 MHz to 800 MHz 800 MHz to.5 GHz W d= (3.5/U1) P d= (3.5/E 1 ) P d= (7/E 1 ) P 0.01 Not applicable 0.1 0.3 0.1 Not applicable 0.38 0.73 1 Not applicable 1.0.30 10 Not applicable 3.79 7.7 100 Not applicable 1.00 3.00 For transmitters whose maximum nominal power is not indicated in the above table, the recommended protective distance d can be determined in meters (m), using the equation affiliated with the corresponding column. P is the maximum nominal power of the transmitter in watt (W) according to the indications of the manufacturer of the transmitter. COMMENT 1: With 80 MHz and 800 MHz the higher frequency range is valid. COMMENT : These guidelines may not apply in every case. The propagation of electromagnetic variables is influenced by absorptions and reflections of buildings, objects and people. MHW 0005 DK 1664 Version 001 1/01/018 custo med GmbH [] ABPM Hardware, custo screen 300/400/pediatric page 0

.9 EC Declaration of Conformity MHW 0005 DK 1664 Version 001 1/01/018 custo med GmbH [] ABPM Hardware, custo screen 300/400/pediatric page 1

MHW 0005 DK 1664 Version 001 1/01/018 custo med GmbH [] ABPM Hardware, custo screen 300/400/pediatric page

.10 List of product components and accessories Set no. Set name Part no. Qty. Set/product designation 58400 custo screen 400 58030 1 custo screen 400 recorder 3070 1 Cuff standard with retainer blue 0011/C 1 Carrying belt standard 17 cm 3060 1 Neoprene carrying case for blood pressure recorder 5104 1) 1 SD card mini GB incl. adapter 003 1) 3 Batteries AA LR6 Mignon 1.5 Volt 10310 custo ECG set 3 K Only for Holter ABPM with custo screen 400 1030 1 custo guard 3 10301/R custo belt 3 red 10118 custo belt 1/3 red extender 10103 1 custo charger single 10110-T 1 Power supply unit with four switch plugs 1011 1 custo guard 3 ECG cable 55551/Z 1 Adjustable neck strap (for custo guard 3 ECG cable and custo flash 5xx) 1169 Starter kit for custo screen combi Only for Holter ABPM with custo screen 400 1608 1) 1 Card reader USB.0 incl. micro USB cable 1600 1 USB connection cable 5058 1 custo com IR infrared interface 58300 custo screen 300 5800 1 custo screen 300 recorder 3070 1 Cuff standard with retainer blue 0011/C 1 Carrying belt standard 17 cm 3060 1 Neoprene carrying case for blood pressure recorder 003 1) 3 Batteries AA LR6 Mignon 1.5 Volt 58500 custo screen pediatric 5801 1 custo screen pediatric recorder 3070 1 Cuff with retainer standard 3071 1 Bandage cuff small, child 3078 1 Bandage cuff pediatric 0015/C 1 Carrying belt for children 96 cm 3066 1 Neoprene carrying case pediatric 3999113 4 Battery compartment cover set for screen pedriatric 003 1) 3 Batteries AA LR6 Mignon 1.5 Volt 1170 Starter kit for custo COM IR 1600 1 USB connection cable 5058 1 custo com IR infrared interface 1) The part numbers of the IT accessories or consumables may change. MHW 0005 DK 1664 Version 001 1/01/018 custo med GmbH [] ABPM Hardware, custo screen 300/400/pediatric page 3

Accessories Part no. Set/product designation Blood pressure cuffs 3070 Cuff with retainer standard 307 Cuff with retainer x-large 3073 Cuff with retainer xx-large 3071 Bandage cuff small, child 3075 Bandage cuff standard 3076 Bandage cuff xx-large 3078 Bandage cuff pediatric 3077 custo screen protect hygiene set: Six fleece pads for custo med blood pressure cuffs in the sizes standard, XL, XXL and a washing bag Carrying belts 0011/C Carrying belt standard 17 cm 001/C Carrying belt long 155 cm 0015/C Carrying belt for children 96 cm Carrying cases 3060 Neoprene carrying case for blood pressure recorder 3066 Neoprene carrying case pediatric for blood pressure recorder Recorder parts 3999113 Battery compartment cover set for screen pedriatric (4 motifs) ECG accessories Only for Holter ABPM with custo screen 400 5104 1) SD card mini GB incl. adapter 1011 ECG cable guard 3 55551/Z Adjustable neck strap (for custo guard 3 ECG cable and custo flash 5xx) 10311 Adapter set for custo guard 3: 10106 Cable adapter for adhesive electrodes 10119 Coding rings for cable adapter and guard 3 3065 Neck strap for custo guard case 3064 Carrying case for custo guard 1011 Cable adapter set for adhesive electrodes for custo guard 3: 10106 Cable adapter for adhesive electrodes 10119 Coding rings for cable adapter and guard 3 10301/R custo belt 3 red 10118 custo belt 1/3 red extender 3064 custo guard carrying case when using cable adapters 3065 Neck strap for custo guard carrying case 10116 custo charger single set: 10103 custo charger single 10110-T Power supply unit with four switch plugs 1601 micro USB cable.0, A-plug, 1.5 m for custo kybe, watch, charger 1) The part numbers of the IT accessories or consumables may change. MHW 0005 DK 1664 Version 001 1/01/018 custo med GmbH [] ABPM Hardware, custo screen 300/400/pediatric page 4

Manufacturer's contact details: custo med GmbH Maria-Merian-Straße 6 8551 Ottobrunn Germany Phone: +49 (0) 89 710 98-00 Fax: +49 (0) 89 710 98-10 E-mail: info@customed.de Internet: www.customed.de